Tysabri
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-02-2024
Charakterystyka produktu
(SPC)
21-02-2024
Sprawozdanie z oceny publicznego
(PAR)
04-05-2020
Składnik aktywny:
natalizumab
Dostępny od:
Biogen Netherlands B.V.
Kod ATC:
L04AA23
INN (International Nazwa):
natalizumab
Grupa terapeutyczna:
Selective immunosuppressants
Dziedzina terapeutyczna:
Multiple Sclerosis
Wskazania:
Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1), , or, Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Podsumowanie produktu:
Revision: 41
Status autoryzacji:
Authorised
Data autoryzacji:
2006-06-27
Ulotka dla pacjenta
57
B. PACKAGE LEAFLET
58
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TYSABRI 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
natalizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
In addition to this leaflet you will be given a patient alert card.
This contains important safety
information that you need to know before and during treatment with
Tysabri.
•
Keep this leaflet and the patient alert card. You may need to read
them again. Keep the leaflet
and patient alert card with you during treatment and for six months
after the last dose of this
medicine , as side effects may occur even after you have stopped
treatment.
•
If you have any further questions, ask your doctor.
•
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
WHAT TYSABRI IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TYSABRI
3.
HOW TYSABRI IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TYSABRI
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TYSABRI IS AND WHAT IT IS USED FOR
Tysabri is used to treat multiple sclerosis (MS). It contains the
active substance natalizumab. This is
called a monoclonal antibody.
MS causes inflammation in the brain that damages the nerve cells. This
inflammation happens when
white blood cells get into the brain and spinal cord. This medicine
stops the white blood cells getting
through to the brain. This reduces nerve damage caused by MS.
SYMPTOMS
OF MULTIPLE SCLEROSIS
The symptoms of MS vary from patient to patient, and you may
experience some or none of them.
THEY MAY INCLUDE:
walking problems, numbness in the face, arms or legs; problems with
vision;
tiredness; feeling off-balance or light headed; bladder and bowel
problems; difficulty in thinking and
concentrating; depression; acute or chronic pain; sexual problems;
stiffness and muscle spasms.
When the symptoms flare up, it is called a
_relapse_
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tysabri 300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 20 mg of natalizumab.
When diluted (see section 6.6), the solution for infusion contains
approximately 2.6 mg per mL of
natalizumab.
Natalizumab is a recombinant humanised anti-α4-integrin antibody
produced in a murine cell line by
recombinant DNA technology.
Excipient with known effect
Each vial contains 2.3 mmol (or 52 mg) sodium (see section 4.4 for
further information).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Colourless, clear to slightly opalescent solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tysabri is indicated as single disease modifying therapy in adults
with highly active relapsing
remitting multiple sclerosis (RRMS) for the following patient groups:
•
Patients with highly active disease despite a full and adequate course
of treatment with at least
one disease modifying therapy (DMT) (for exceptions and information
about washout periods
see sections 4.4 and 5.1)
or
•
Patients with rapidly evolving severe RRMS defined by 2 or more
disabling relapses in one
year, and with 1 or more Gadolinium enhancing lesions on brain
Magnetic Resonance Imaging
(MRI) or a significant increase in T2 lesion load as compared to a
previous recent MRI.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy is to be initiated and continuously supervised by specialised
physicians experienced in the
diagnosis and treatment of neurological conditions, in centres with
timely access to MRI.
Patients treated with this medicinal product must be given the patient
alert card and be informed about
the risks of the medicinal product (see also package leaflet). After 2
years of treatment, patients should
be re-informed about the risks, especially the increased risk of
Progressive Multifocal
Leukoencephalopathy (PML), and should be instructed toge
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